EYP-1901 for Diabetic Macular Edema

(VERONA Trial)

No longer recruiting at 5 trial locations

Overseen By Ramiro Ribeiro, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: EyePoint Pharmaceuticals, Inc.

Must be taking: Anti-VEGF

Disqualifiers: Ocular disease, Inflammation, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EYP-1901 (also known as DURAVYU) for individuals with diabetic macular edema (DME), a condition that causes vision problems due to swelling in the eye from diabetes. The study compares two different doses of EYP-1901 with an existing treatment, aflibercept, to determine which is more effective and safer. Individuals with diabetes who have previously received eye treatments for DME and meet certain vision criteria might be suitable candidates. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in DME treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that EYP-1901 is generally well-tolerated. An earlier study reported no serious side effects related to the drug, either in the eye or throughout the body. Participants did not experience severe negative effects from the treatment. Additionally, the data indicated that EYP-1901 improved vision over time and was safe to use.

These findings suggest that EYP-1901 is safe based on earlier trials. While this trial phase continues to collect more detailed safety data, current evidence points to a positive safety record for EYP-1901. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Researchers are excited about EYP-1901 for diabetic macular edema because it offers a unique approach compared to current treatments like aflibercept. Unlike standard therapies, which often require frequent injections, EYP-1901 is designed to be administered as a single dose, potentially reducing the treatment burden for patients. Additionally, EYP-1901 targets the condition with its unique formulation, which could provide sustained therapeutic effects and improved patient compliance. This innovative delivery method and long-lasting action have the potential to transform how diabetic macular edema is managed, offering new hope for those affected by this vision-threatening condition.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

Research has shown that EYP-1901 holds promise for treating eye conditions like wet age-related macular degeneration and diabetic macular edema (DME). In earlier studies, patients who received EYP-1901 improved their vision, gaining an average of about 9 letters on an eye chart, which measures visual acuity. This trial will evaluate two doses of EYP-1901, 1343 µg and 2686 µg, to determine their effectiveness in improving vision by reducing eye swelling, a major issue in DME. The treatment works by slowly releasing medication over time, aiming for long-lasting effects with fewer injections. Although more information is needed, the early findings offer encouragement for those considering this treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Ramiro Ribeiro, MD

Principal Investigator

EyePoint Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for people with diabetic macular edema (DME), a type of eye swelling. Participants must have a certain level of vision in the affected eye and have been treated with an anti-VEGF injection within the last 6 months but not less than 8 weeks before screening.

Inclusion Criteria

My vision in the study eye is between 20/200 and 20/32.

I have been diagnosed with diabetes affecting my eye before the screening visit.

I've had an eye injection treatment in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either EYP-1901 or Aflibercept

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EYP-1901

Trial Overview The study compares two doses of EYP-1901, which is administered as an intravitreal insert, against aflibercept injections. It's designed to assess how well these treatments work and their safety for patients with DME.

How Is the Trial Designed?

Group I: EYP-1901 2686 µg Experimental Treatment 1 Intervention

EYP-1901 2686 µg, single dose

Group II: EYP-1901 1343 µg Experimental Treatment 1 Intervention

EYP-1901 1343 µg, single dose

Group III: Aflibercept Active Control 1 Intervention

Aflibercept 2 mg/0.05mL solution, single dose

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials

19

Recruited

2,700+

Citations

1. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-pivotal-phase-3-program-initiation-duravyutm

EyePoint Announces Pivotal Phase 3 Program Initiation for ... DURAVYU has efficacy data across approximately 140 wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) patients in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11497975/

Role of EYP-1901 in neovascular age-related macular ... EYP-1901 (Duravyu) has demonstrated promising outcomes in Phases I and II clinical trials for the treatment of neovascular age-related macular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06099184?utm_source=trialradar

Study of EYP-1901 in Patients With Diabetic Macular ... A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different ...

4. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-announces-positive-interim-16-week-data

EyePoint Pharmaceuticals Announces Positive Interim 16 ... DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a gain of +8.9 letters compared to baseline -.

5. retinalphysician.com retinalphysician.com/issues/2025/may/rwc24/

EYP-1901 Shows Durable, Sustained Efficacy in VERONA It has shown very favorable results in the treatment of neovascular AMD at phase 2 in a large controlled clinical trial and is now in phase 3 ...

6. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-presents-interim-masked-safety-data-and

EyePoint Pharmaceuticals Presents Interim Masked Safety ... Interim safety data from the Phase 2 DAVIO 2 trial continues to demonstrate EYP-1901 is well tolerated with no reported drug-related ocular or systemic SAEs.

7. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-positive-six-month-results-phase-2-verona

EyePoint Announces Positive Six-Month Results for the Phase ... Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06099184

Study of EYP-1901 in Patients With Diabetic Macular ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME.

9. sec.gov sec.gov/Archives/edgar/data/1314102/000095017025064983/eypt-ex99_1.htm

EX-99.1 The 24-week data demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile.